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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)

Primary Purpose

Complex Regional Pain Syndrome

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lumbar sympathetic block
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Complex Regional Pain Syndrome focused on measuring complex regional pain syndrome, lumbar sympathetic blockade, photoplethysmography, diagnostic lumbar sympathetic blockade

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Physically examined for complex regional pain syndrome on lower extremity,
  • Scheduled for diagnostic lumbar sympathetic blockade.

Exclusion Criteria:

  • Graded as ASA 3 or higher,
  • Below 18 or above 70 years of age, or
  • Had any other contraindication for regional anesthesia.

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

lumbar sympathetic block

contralateral side

Arm Description

Unilateral lumbar sympathetic blockade using chirocaine

Outcomes

Primary Outcome Measures

Index of sympathetic block
change of slope of signals of the alternative current and the direct current from foot The baseline is defined as the point of surgical drap. The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection

Secondary Outcome Measures

skin temperature changes
foot temperature change from baseline
electrocardiogram
heart rate variability measurement

Full Information

First Posted
May 19, 2010
Last Updated
June 4, 2010
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01134289
Brief Title
Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block
Acronym
park001
Official Title
An Analysis of Photoplethysmographic Signal in Diagnostic Lumbar Sympathetic Block for Complex Regional Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to compare the alternative current and the direct current signal changes of photoplethysmography between both feet during one side lumbar sympathetic block. The hypothesis is that signal changes occur earlier than other indices to decide whether it is successful following lumbar sympathetic block on only one-side.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome
Keywords
complex regional pain syndrome, lumbar sympathetic blockade, photoplethysmography, diagnostic lumbar sympathetic blockade

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lumbar sympathetic block
Arm Type
Active Comparator
Arm Description
Unilateral lumbar sympathetic blockade using chirocaine
Arm Title
contralateral side
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
lumbar sympathetic block
Other Intervention Name(s)
0.25% bupivacaine (Chirocaine, Abbott, Elverum, Norway), C-arm (OEC 9800 plus, GE Medical Systems, Salt Lake City, UT), Chiba needle (Cook Inc., Bloomington, IN)
Intervention Description
unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
Primary Outcome Measure Information:
Title
Index of sympathetic block
Description
change of slope of signals of the alternative current and the direct current from foot The baseline is defined as the point of surgical drap. The end of procedure is decided when the temperature of foot is increased more than 2 degrees from baseline within 20 minutes after local anesthetics injection
Time Frame
1 minute at intervals from baseline through end of procedure
Secondary Outcome Measure Information:
Title
skin temperature changes
Description
foot temperature change from baseline
Time Frame
1 minute at intervals during procedure
Title
electrocardiogram
Description
heart rate variability measurement
Time Frame
1 minute at intervals from baseline through end of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physically examined for complex regional pain syndrome on lower extremity, Scheduled for diagnostic lumbar sympathetic blockade. Exclusion Criteria: Graded as ASA 3 or higher, Below 18 or above 70 years of age, or Had any other contraindication for regional anesthesia.
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Young Park, MD
Phone
82-2-2072-0881
Email
soo02@snu.ac.kr

12. IPD Sharing Statement

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Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block

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